The United States Food and Drug Administration (FDA) regularly revises its guidance for blood and plasma donation, keeping up with the latest findings and advances in these two domains.
In its most recent revision, the FDA addressed several issues. First, it addressed the risk of transmitting the Creutzfeldt-Jacob Disease (CJD) through blood and plasma products. The FDA’s updated guidelines now recommend blood and plasma collection centers to screen for the rare disease as well as other Transmissible Spongiform Encephalopathies (TSEs) — a group of rare degenerative brain disorders. Those who test positive for them, or have blood relatives who have been diagnosed with them, are to be indefinitely deferred.
Second, the FDA clarified its stance on patients who have received a cadaveric pituitary growth hormone or allogeneic human cadaveric dura mater transplant. Many believed that its previous guidance was opaque due to less-specific terminology. However, this revision offers a clarified position, and recommends deferring these patients indefinitely, since they are likely to be infected by and hence transmit CJD.
Finally, the FDA has removed indefinite deferrals for potential donors who have spent five or more years in Europe since 1980.
These strict standards ensure that the life-saving therapies patients of rare diseases receive are safe and effective.
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